Trial reportNature cancer2023
Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC.
Trial report in Nature cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03789604 (A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects), which is not on this map. Cited by 25 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects
Who cites it
25 citing papers in PubMed, 9 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Use of PD-1/PD-L1 inhibitors in non-small cell lung cancer in elderly patients: a meta-analysis and systematic review of randomized clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Pooled it
- Pooled it
- First-line PD-1/PD-L1 inhibitors plus chemotherapy vs. chemotherapy alone in stage IIIB-IV non-squamous NSCLC: an updated meta-analysis of phase 3 RCTs.BMC cancer · 2025Pooled it
- Pooled it
- Do age and performance status matter? A systematic review and network meta-analysis of immunotherapy studies in untreated advanced/metastatic non-oncogene addicted NSCLC.Frontiers in immunology · 2025Pooled it
- The benefits and risks of adding PD-1/PD-L1 inhibitors to chemotherapy for stage IIIb-IV non-small-cell lung cancer: an updated meta-analysis based on phase 3 randomized controlled trials.Frontiers in oncology · 2025Pooled it
- First-line immunochemotherapy for advanced NSCLC in Asian patients: a meta-analysis of phase 3 RCTs.Frontiers in oncology · 2025Pooled it
- Comparison of efficacy and safety of PD-1/PD-L1 combination therapy in first-line treatment of advanced NSCLC: an updated systematic review and network meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Pooled it
- Immune checkpoint inhibitors plus platinum-based chemotherapy compared to platinum-based chemotherapy with or without bevacizumab for first-line treatment of older people with advanced non-small cell lung cancer.The Cochrane database of systematic reviews · 2024Pooled it
- Efficacy and safety of first-line sintilimab plus anlotinib versus chemotherapy for metastatic non-small cell lung cancer: a phase II, open-label, randomized controlled trial.Cancer communications (London, England) · 2025Trial
- Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study.Journal for immunotherapy of cancer · 2024Trial
- First-line pembrolizumab plus chemotherapy versus bevacizumab plus chemotherapy in response and survival outcomes in PD-L1-negative advanced non-squamous NSCLC: a retrospective comparative cohort study.Translational lung cancer research · 2026Article
- Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone in stage IIIB-IV squamous non-small cell lung cancer: a systematic review and meta-analysis of phase 3 randomized controlled trials.Translational cancer research · 2026Article
- Ophthalmic Immune-Related Adverse Events in Cancer Immunotherapy: Tissue-Specific Mechanisms, Clinical Phenotypes, and Consensus-Based Management.International journal of molecular sciences · 2026Review
- Optimizing PD-1/PD-L1 inhibitors plus chemotherapy for driver mutation-negative non-squamous NSCLC in China: a cost-effectiveness analysis.Frontiers in pharmacology · 2026Article
- Comparative effectiveness and safety of systemic therapies for treatment-naïve, PD-L1 expression <1% advanced NSCLC: a systematic review and network meta-analysis.Translational lung cancer research · 2025Article
- Predictive factors for the efficacy of immune checkpoint inhibitors in advanced non-small cell lung cancer: a retrospective study.Journal of thoracic disease · 2025Article
- Advances in molecular pathology and therapy of non-small cell lung cancer.Signal transduction and targeted therapy · 2025Review
- Vitamin D and Immune Checkpoint Inhibitors in Lung Cancer: A Synergistic Approach to Enhancing Treatment Efficacy.International journal of molecular sciences · 2025Review
- Unravelling T cell exhaustion through co-inhibitory receptors and its transformative role in cancer immunotherapy.Clinical and translational medicine · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
34 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The randomized, double-blinded, multi-center, phase III GEMSTONE-302 ( NCT03789604 ) study evaluated the efficacy and safety of sugemalimab versus placebo in combination with chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (NSCLC). In this study, 479 treatment-naive patients with stage IV squamous or non-squamous NSCLC without known EGFR sensitizing mutations, ALK, ROS1 or RET fusions were randomized (2:1) to receive 1,200 mg of sugemalimab (n = 320) or placebo (n = 159) every 3 weeks in combination with platinum-based chemotherapy for up to four cycles, followed by maintenance therapy with sugemalimab or placebo for squamous NSCLC and sugemalimab or placebo plus pemetrexed for non-squamous NSCLC. Placebo-treated patients could cross over to receive sugemalimab monotherapy on disease progression. The primary endpoint was investigator-assessed progression-free survival (PFS) and the secondary endpoints included overall survival (OS) and objective response rate. Sugemalimab plus chemotherapy has demonstrated significant PFS prolongation in the primary analysis as reported previously. As of 22 November 2021, the prespecified interim OS analysis showed significant improvement with the addition of sugemalimab to chemotherapy (median OS = 25.4 versus 16.9 months; hazard ratio = 0.65; 95% confidence interval = 0.50-0.84; P = 0.0008). Sugemalimab plus chemotherapy provided superior PFS and OS compared to placebo plus chemotherapy, supporting the use of sugemalimab as a first-line treatment option for metastatic NSCLC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.